Press Room

November 8, 2009

The US Food and Drug Administration has awarded FEFA the contract to provide the development of a web-based, metadata driven software tool for clinical protocol review.

 

August 1, 2009

FEFA has been awarded a contract to provide 508 compliance services to the US Food and Drug Administration.

 


Services

FEFA is a full-service CRO, with a diverse and growing suite of services that can be deployed on any scale within the clinical trial process.  We have expert knowledge in clinical trials ranging from complex global trials to regional early phase studies.  We also have detailed experience within highly specialized and targeted patient populations.

Study Start-Up
~ Protocol Development
~ Site Identification and Feasibility Studies
~ Negotiation and Review of Study Budgets and Research Agreements
~ Identification and Recruitment of Qualified Study Sites and Investigators

Data Management
We have extensive data management experience for Phase I-IV clinical trials across a broad range of therapeutic areas and quantitative methods.   These services include electronic data capture expertise to accelerate data collection and study database completion activities.

Project Management
Our project managers focus on providing on-time, on-cost quality deliverables. 

Clinical Monitoring
Our dedicated clinical teams of skilled professionals provide consistent and effective monitoring and interaction with study sites. 

Technology Services
Our appropriate and effective technologies augment proven product development processes. 

Additional Services
~ Patient Recruitment
~ Study File Set-Up
~ Standard Operating Procedures (SOPs) Writing
~ Business Plan Writing
~ Job Description Development
~ Organization of External Consultant Meetings
~ Transition/Rescue Planning and Management